BIOGRAPH MCT FAMILY— 510(k) K123737
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K123737 for BIOGRAPH MCT FAMILY, Substantially Equivalent on 2013-01-29. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Knoxville, TN, US
Recent devices under product code KPS
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allRecalls naming K123737
K-number listed on FDA's recall record- Z-1997-2016 — BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
- Z-1998-2016 — Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
- Z-1999-2016 — BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
- Z-2000-2016 — BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
- Z-2331-2015 — Biograph mCT S(40)-4R, Model Number 10248671
- Z-2332-2015 — Biograph mCT S(64)-4R, Model Number 10248672
- Z-2333-2015 — Biograph mCT X-4R, Model Number 10248670
- Z-2334-2015 — SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743
- Z-2335-2015 — Biograph mCT Flow Edge-4R, Model Number 10528955
- Z-2336-2015 — Biograph 6-4R TruePoint w/ TrueV, Model Number 10097290
- Z-2337-2015 — Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302
- Z-2338-2015 — Biograph 64-3R TruePoint w/ TrueV, Model Number 10097301
- Z-0807-2015 — Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
- Z-0808-2015 — Biograph mCT Flow 40-4R, System Material Number 10529159. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
- Z-0809-2015 — Biograph mCT X-4R, System Material Number 10248670. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
- Z-0810-2015 — Biograph mCT S(64)-4R, System Material Number 10248672. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
- Z-0811-2015 — Biograph mCT S(40)-4R, System Material Number 10248671. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123737.
Data sourced from openFDA. This site is unofficial and independent of the FDA.